Clinical Programs: Vascugel Overview

Overview: Vascugel is under investigation for enhancing blood vessel repair and promoting vascular health in hemodialysis patients. In May 2009, Vascugel received an Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

To evaluate the clinical potential of Vascugel, Pervasis is conducting its “V-HEALTH” (Vascular Intimal Hyperplasia: Extending Arterial and Venous Patency, Limiting Vascular Trauma, and Inhibiting Hyperplasia while Re-establishing Vascular Health) Phase 1 and Phase 2 clinical trials in patients with end-stage renal disease (ESRD) undergoing the placement of an arteriovenous (AV) graft or AV fistula for hemodialysis access.

V-HEALTH Trials: The V-HEALTH trials evaluated the safety and efficacy of Vascugel in patients receiving an AV fistula or AV graft. The primary safety endpoints included the incidence of local wound infection, intervention (surgical, endovascular or percutaneous) and acute thrombosis within 30 days post-surgery.

Data from the trial showed that placement of Vascugel around the vessel at the time of AV access creation was well tolerated, with a lower incidence of local wound infection, access intervention and acute thrombosis compared to placebo. In addition, patients treated with Vascugel demonstrated a trend toward higher patency (lack of vessel obstruction) rates, extended time to first intervention, and greater vessel lumen diameters at six months.

Next Steps: In January 2010, Pervasis reached an agreement with the FDA on the design of a pivotal Phase 3 clinical trial for Vascugel. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure. Pervasis expects to initiate the Phase 3 study in 2010.

Safety Data from Phase 2 Study of Vascugel®

The primary safety outcome analysis from a Phase 2 study of Vascugel® indicated fewer interventions, wound infection and thrombosis in patients treated with Vascugel compared to placebo treatment.

Efficacy Data from Phase 2 Study of Vascugel®

Primary Patency (no intervention)

Assisted Primary Patency (intervention required)

The primary efficacy analysis from a Phase 2 study of Vascugel® in patients receiving an arteriovenous graft showed greater patency rates among patients treated with Vascugel compared to placebo treatment. Patency rates were analyzed using the Kaplan Meier product limit method.